Cleared Traditional

K903854 - RAPITEX(R) ASL NEW

K903854 is an FDA 510(k) clearance for RAPITEX ASL NEW, manufactured by Behring Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K903854 · Behring Diagnostics, Inc. · Microbiology device
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Jan 1991
Decision
160d
Days
Class 1
Risk

K903854 is an FDA 510(k) clearance for the RAPITEX(R) ASL NEW. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on January 28, 1991 after a review of 160 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3720 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K903854

510(k) Number K903854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date January 28, 1991
Days to Decision 160 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 102d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

GTQ Device Classification - Class 1, General Controls

Product Code GTQ Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GTQ Antistreptolysin - Titer/streptolysin O Reagent

All 23
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K903854.
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991
QM300 CONTROL G PACK
K910887 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991
TARGET ASO TEST
K910073 · Texas Immunology, Inc. · May 1991
ASO-CUBE(TM)
K901371 · Difco Laboratories, Inc. · May 1990
LASER ASO KIT
K854039 · Behring Diagnostics, Inc. · Oct 1985
V-TREND ASO PLUS LATEX TEST
K853857 · Texas Immunology, Inc. · Oct 1985